Safety Risk Communication for Medical Products
What you will learn
- Gain the ability to evaluate risk communication approaches across the medicinal product lifecycle in light of scientific ‘good practices’ and emerging evidence.
- Understand the opportunities for enhancing the effectiveness of safety risk communication in light of evolving regulatory expectations.
- Leave with cutting edge, patient-centered solutions for safety risk communication and risk management strategies.
Who should attend?
This program is designed for professionals involved in:
- Drug safety and pharmacovigilance, especially safety evaluation and periodic safety reporting
- Clinical trial design and operation
- Quality systems
- Medical writing
- Regulatory strategy and regulatory affairs
- Regulatory policy
- Labeling operations and label development
- Risk management plan development, and risk minimization program design, implementation and evaluation (including for formal EU Risk Management Plans and US REMS)
- Benefit-risk assessment of medicinal products
At the conclusion of this course, participants should be able to:
- Identify good practices and principles for designing effective risk communication messages and tools
- Describe the current regulatory expectations regarding safety risk communication across the medicinal product lifecycle
- Recognize the different types of communication challenges associated with medicinal product risks
- Demonstrate an awareness of risk communication as an integral component of therapeutic risk management
- Discuss the role of implementation in the success of risk communication efforts locally, regionally, and globally
- Evaluate risk communication strategies for feasibility, effectiveness, and patient-centeredness
- Name key future trends in safety risk communication